Quality Control and Standardization of Herbal Medicines From Cultivation of Medicinal Plants to its Clinical Application


Mohammad Kamil and Mazen Ali Naj


Traditional & Complementary Medicine Exhibition 2007 (TCME 2007), Putra World Trade Centre (PWTC), Kuala Lumpur, Malaysia




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In spite of recent developments of antibiotics and newer synthetic drugs, a vast majority of people depend on traditional medicines for their primary health care needs and it can safely presumed that a major part of traditional therapy involves the use of plant extracts or their active principles. In the recent years with ever growing commercialization in the field of herbal medicines, there has been an instant demand for quality control of the drugs used in this system. The studies on the identity, purity and quality of the genuine drug will enhance information in checking the adulteration. A set of standards would not doubt be detterent on substitution and adulteration and also an aid for ‘Drug law Enforcement’. In the present paper an attempt has been made for a sequential study of the Quality Control of Herbal Medicinal Products ( HMP ) starting from 1)Selection of Medicinal Plants 2).Good Agricultural Practices (GAP ) 3) Cultivation 4)Good Field Collection Practices(GFCP) 5) Organized and Unorganized Drugs 6)Source and Period of Collection; 7) Identi¿cation; 8) Storage 9) Chemical Standardisation 10) Assay 11)Good Manufacturing Practices (GMP)  12 ) Pharmacological study to Clinical Approach , with special reference to maintain Standardisation at each and every stage. Besides above protocols , this study deals with preliminary examination of a medicinal plant, its morpho-anatomical, pharmacognostic, physicochemical and analytical parameters, foreign organic matter, pesticide residue, radioactive and microbial contamination, chemical assay,  finger printing of the successive extractives using Accelerated Solvent Extractor ( ASE ),spectroscopic and spectrometric techniques e.g. IR ,UV, TLC & HPLC, GC/MS, LC/MS, phytochemical screening, quantitative analysis of inorganic constituents through Atomic Absorption Spectrometer and over an above discussed in detail the challenges of standardisation with special reference to marker compounds in plant species and their fingerprinting.Different stages, i.e Quality control studies of Raw Medicinal Plants, Controled Studies of Method of Processing, Quality Control Studies of Finished Product, Standardisation Proceedures at each stage from birth of the plants up to clinical application of herbal medicine have been described with reference to some medicinal herbs. An emphasis have been given on the protocols which are required for Registration of Herbal Medicinal Products ( HMP).